Provide Quality Assurance support for SI-BONE products, ensuring that our actions result in meeting our customer needs while maintaining compliance with federal law and applicable standards.
In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO 14971), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing. The employee has the responsibility and authority to report any such instances to Regulatory and their respective management team.
The employee must at all times act and conduct company business in an honest, ethical and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code, and all applicable laws and regulations, whether national, regional, state, or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code of Conduct, or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.
Perform Quality role for New Product Development, including Design Change (DC) projects and Non-Standard Products (NSPs)
Support New Product Development activities, such as assessment and characterization of design risks, design verification and validation (V&V) testing, including sterilization validation, biocompatibility testing, and packaging validation
Provide input on design-for-quality issues
Develop sterilization and monitoring requirements for new products.
Represent QA on project teams
Develop/update hazard analyses
Provide direction in developing supplier and incoming inspection plans, sampling plans, inspection & acceptance criteria for new products
Perform incoming inspection for prototypes and V&V parts
Provide direction for supplier controls for new products, DCs, and NSPs, including performing vendor audits and evaluations
Manage ASL for new products, DCs, and NSPs, but may support Sustaining suppliers as required
Support CAPAs, NMRs, Deviations, Extension/Scope Changes for new products, DCs, and NSPs
Develop/use quality tools to establish approval criteria to ensure the identification of quality failure concerns for both internally- and externally- manufactured parts, assemblies, and finished devices for new products
Develop, review and approve process and equipment validations/qualifications for New Product Development and DC applications
Perform new product process evaluations, including process capability studies, to identify areas for improvement and to reduce variability and lower total quality costs. Recommend solutions to identified problems. Implement approved changes using sound quality engineering principles and fully document requirements on a timely basis.
Support IQ, OQ, PQ (installation, operational, and process qualification) – Not including software validation. Write test protocols and implement process validation procedures in accordance with relevant standards and regulations.
Support real-time packaging validation testing of new products
Assist Regulatory Affairs and Engineering personnel in new product/process design to assure effective control procedures are established. Participate actively in product and process start-ups.
Support internal audits to assess compliance to standards and to the internal QMS
Manage NSP, DC, DHF logs and files in Box
Manage International files
Support the SI-BONE QMS
Other duties as assigned
Bachelor’s degree in engineering or technical science
8+ years of directly relevant experience with a minimum of 6 years of recent experience in FDA/cGMP or other regulated environment(s)
ASQ CQE certification preferred
Substantial knowledge of industry standards (FDA QSRs, ISO, MEDDEV, etc.).
Experienced in QMS requirements and able to provide guidance on industry practices. This includes design control, production & process controls, supplier controls, corrective and preventive action, management review, and non-conforming material controls.
Demonstrated ability to drive and deliver innovative, effective, and timely solutions. Ability to mentor others in best practices and industry standards.
Demonstrated ability to acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements
Strong knowledge of statistical quality tools with process capability and statistical quality control methodologies; demonstrated ability to determine sampling plans based on confidence and reliability
Excellent verbal and written communication skills
Must be a team player
Internal Number: 01
About SI-BONE, Inc.
SI-BONE® was founded in April, 2008 as a spin out when Wright Medical bought INBONE Technologies. INBONE, with the ENDO-FUSETM Intra-Osseos Fusion System, was founded by Dr. Mark Reiley, the inventor of kyphoplasty and the vertebral fracture treatment.
SI-BONE developed an innovative, patented implant for some causes of SI joint pain. The iFuse Implant System® provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery. The iFuse Implant System uses the same titanium implant technology that has been used in the ENDO-FUSE System. To date, more than 30,000 minimally invasive surgical SI joint fusions have been performed with the iFuse Implant System by more than 1,500 surgeons worldwide.
SI-BONE is managed by an experienced team of executives from Kyphon, Medtronic, INBONE, Saint Francis and several start-up orthopedic and spine companies.
According to the National Institute of Neurological Disorders and Stroke (a division of NIH), "Americans spend at least $50 billion each year on low back pain." Low back pain is the most common cause of job-related disability and a leading contributor to missed work. Several leading orthopedic publications over... the last few years have stated that anywhere from 15-25% of all low back pain is SI joint in origin. According to a study by Bernard and Kirkaldy-Willis, over twenty two percent (22%) of individuals who presented with lower back pain actually had sacroiliac (SI) joint pain. A wealth of published clinical literature indicates that sacroiliac (SI) joint pain frequently mimics discogenic or radicular low back pain, resulting in many patients receiving lumbar fusion instead of sacroiliac (SI) joint fusion.*
SI-BONE is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.